Protalix Biotherapeutics Inc. (PLX)
Protalix Revenue Miss Overshadowed By Milestone-Backed 2026 Guidance
Protalix BioTherapeutics reported weaker FY25 results but issued robust FY26 revenue guidance of $78–83 million, well above consensus. PLX's growth thesis centers on Elfabrio's EU approval and once-every-4-weeks dosing, offering a clear competitive and patient adherence advantage. Chiesi's contribution is expected to exceed 50% revenue growth in 2026, improving margin mix and earnings predictability despite near-term volatility.
Protalix BioTherapeutics, Inc. (PLX) Q4 2025 Earnings Call Transcript
Protalix BioTherapeutics, Inc. (PLX) Q4 2025 Earnings Call Transcript
Protalix BioTherapeutics advances Fabry disease and gout programs during 2025
Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) reported its 2025 financial results and outlined recent regulatory, clinical and commercial developments, including a new European approval for its Fabry disease therapy and updated guidance for 2026. "2025 was a year of meaningful progress for Protalix, marked by strong commercial execution with our partners and important advances and strategic direction across our clinical and preclinical pipeline," the company's CEO Dror Bashan said.
Protalix BioTherapeutics and partner secure EU approval for new Fabry disease dosing regimen
Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) announced that the European Commission has approved a new dosing regimen for pegunigalsidase alfa for adults with Fabry disease who are stable on enzyme replacement therapy (ERT), triggering a $25 million regulatory milestone payment from partner Chiesi Global Rare Diseases. The approval allows eligible patients to receive the therapy at a dose of 2 mg/kg every four weeks, instead of the previous every-two-weeks schedule.
A March Decision That Could Change Protalix BioTherapeutics Outlook
Protalix Bio Therapeutics (PLX) received a positive CHMP opinion for Elfabrio's every-four-weeks dosing in stable adult Fabry patients, pending EC approval by March. PLX's Elfabrio could halve infusion frequency, improving patient quality of life and potentially strengthening its competitive position in the Fabry market. Elfabrio drove over half of PLX's FY24 product revenue, with sales rising and a potential $25 million milestone tied to EU approval.
Protalix wins EU panel backing for expanded dosing of Fabry disease drug
Protalix Biotherapeutics Inc (NYSE-A:PLX, FRA:PBDA) said on Friday that the European Medicines Agency's human medicines committee has issued a positive opinion recommending approval of an expanded dosing regimen for Elfabrio, its treatment for Fabry disease, in adult patients. The Committee for Medicinal Products for Human Use (CHMP) recommended approval of a 2 mg/kg every-four-weeks dosing schedule for Elfabrio in adult Fabry patients who are stable on enzyme replacement therapy, following a re-examination of the application.
Protalix BioTherapeutics CEO outlines 2026 priorities, highlights progress across clinical pipeline
Protalix Biotherapeutics Inc (NYSE-A:PLX) on Monday shared an update from its CEO Dror Bashan, who highlighted the company's strategic priorities for 2026, with a focus on advancing its clinical pipeline while building on its partnered commercial base. In a letter to stockholders, Bashan wrote that Protalix remains focused on “building with our partners a growing, profitable business and an innovative pipeline for patients with high-need rare diseases.
Protalix BioTherapeutics partners with Secarna Pharmaceuticals on rare kidney disease drug development
Protalix Biotherapeutics Inc (NYSE-A:PLX) announced that it has entered into a collaboration and option agreement with Secarna Pharmaceuticals to jointly develop new antisense oligonucleotide (ASO) therapies targeting rare kidney diseases, the companies said Tuesday. Secarna, headquartered in Martinsried, Germany, specializes in the discovery and development of oligonucleotide-based therapeutics.
Protalix and Chiesi seek EMA re-examination of Elfabrio dosing opinion
Protalix Biotherapeutics Inc (NYSE-A:PLX) and Chiesi Global Rare Diseases said they have requested a re-examination of a recent negative opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) concerning a new dosing regimen for Elfabrio. The CHMP's opinion relates to a proposal to add a 2 mg/kg every-four-weeks (E4W) dosing option to the currently approved 1 mg/kg every-two-weeks (E2W) regimen for the treatment of adults with Fabry disease.
Protalix, Chiesi reaffirm commitment to Fabry disease patients after EMA panel setback
Protalix Biotherapeutics Inc (NYSE-A:PLX) and Chiesi Global Rare Diseases said they remain committed to advancing treatment options for Fabry disease after a European Medicines Agency committee declined to recommend approval of a new, less frequent dosing regimen for Elfabrio (pegunigalsidase alfa). The Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion on the proposed dosing schedule of 2 mg/kg every four weeks, in addition to the already approved 1 mg/kg every two weeks regimen.
Protalix: Speculative Buy On Promising Plant-Cell Platform And Elfabrio Ramp
Protalix BioTherapeutics uses a plant-cell approach with ProCellEx. This has given it two approved ERTs plus PRX-115 and PRX-119. Its main focus is on a growing rare-disease pipeline. The main value driver is Elfabrio, which targets Fabry's rapidly growing TAM. PLX's valuation multiples also look compelling, especially after the stock retraced significantly in the last few weeks.
Protalix BioTherapeutics, Inc. (PLX) Q2 2025 Earnings Call Transcript
Protalix BioTherapeutics, Inc. (NYSE:PLX ) Q2 2025 Earnings Call August 14, 2025 8:30 AM ET Company Participants Dror Bashan - President, CEO & Director Eyal Rubin - Senior VP, CFO, Treasurer & Corporate Secretary Conference Call Participants Daniel Robert Smith - H.C. Wainwright & Co, LLC, Research Division John D.
